DITEBOOSTER SUSPENSION FOR INJECTION IN PRE-FILLED SINGLE-DOSE SYRINGE

Introduction

Package Leaflet: Information for the User

diTeBooster

Injectable suspension, pre-filled monodose syringe

Injectable suspension, vial

Vaccine against diphtheria and tetanus (adsorbed, reduced antigen content)

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is diTeBooster and what is it used for.
2. What you need to know before you are vaccinated with diTeBooster.
3. How to be vaccinated with diTeBooster
4. Possible side effects
5. Storage of diTeBooster
6. Package contents and further information.

1. What is diTeBooster and what is it used for

diTeBooster is a vaccine that protects against diphtheria and tetanus.

diTeBooster stimulates the body to produce antibodies against diphtheria and tetanus.

This vaccine can be used to revaccinate children (from 5 years of age) and adults who have already received primary vaccination against diphtheria and tetanus.

This vaccine is used to vaccinate children (from 5 years of age) and adults who have forgotten, not completed, or not received primary vaccination against diphtheria and tetanus.

In the case of deep or potentially contaminated wounds, this vaccine can be used as prevention against tetanus and as a booster against diphtheria.

2. What you need to know before you are vaccinated with diTeBooster

You should not be vaccinated with diTeBooster

• if you are allergic to the active substances or to any of the other ingredients of the vaccine (listed in section 6).
• if you have experienced severe side effects after previous vaccinations.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are vaccinated with diTeBooster.

• if you have any illness. In the case of acute illness with fever, vaccination should be postponed.
• if you are receiving any treatment that reduces the immune response (e.g., corticosteroids) or if you have any illness that increases the risk of bleeding.
• if you have any allergies.
• if you have not felt well after previous vaccinations.
• if you are allergic to formaldehyde. The vaccine may contain traces of formaldehyde used during the manufacturing process.

Children and adolescents

Children under 5 years of age should not be vaccinated with diTeBooster.

Other medicines and diTeBooster

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

diTeBooster can be administered together with other vaccines, but in separate injections.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before you are vaccinated with diTeBooster.

Pregnancy

There are not enough data on the use of diTeBooster in pregnant women. If you are pregnant, your doctor will decide if the risk of tetanus and diphtheria infection is higher than the possible risk to the fetus from vaccination.

Breastfeeding

There are not enough data on the use of diTeBooster during breastfeeding, but no harmful effects of the vaccine have been reported in breastfed infants.

Driving and using machines

diTeBooster should not affect your ability to drive or use machines.

diTeBooster contains sodium

diTeBooster contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to be vaccinated with diTeBooster

The doctor or nurse will administer the vaccine intramuscularly.

The recommended dose is 0.5 ml for children (5 years of age or older) and adults.

If you or your child have not been previously vaccinated against diphtheria and tetanus, you may need to be vaccinated more than once. Follow your doctor's instructions.

If you have any other questions about the use of this vaccine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Severe side effects

• Severe allergic reactions (e.g., difficulty breathing, difficulty swallowing, itching in hands and feet, swelling of the face and around the eyes).

If you notice any of these reactions, contact your doctor immediately.

Other side effects are:

Very common (may affect more than 1 in 10 people)

• Mild redness and swelling at the injection site.
• Pain and itching at the injection site.
• Headache and fatigue

Common (may affect up to 1 in 10 people)

• General feeling of being unwell (feeling sick) and fever (temperature of 38°C or higher).
• Severe redness and swelling of 5 cm or more at the injection site
• Muscle pain.
• Dizziness.

• Nausea, vomiting, and diarrhea.

Uncommon(may affect up to 1 in 100 people)

• Eczema and skin inflammation (dermatitis).

Rare(may affect up to 1 in 1,000 people)

• High fever (temperature above 40°C).
• Persistent itching nodules (granuloma) or sterile abscess at the injection site.
• Hives.

Very rare (may affect up to 1 in 10,000 people)

• Fainting.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of diTeBooster

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Discard the vaccine safely if it has been frozen.

Do not use diTeBooster after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of diTeBooster

• The active substances are:

1 dose (=0.5 ml) contains at least 2 international units of purified diphtheria toxoid and at least 20 international units of purified tetanus toxoid adsorbed on hydrated aluminum hydroxide, corresponding to 0.5 mg of aluminum.

Aluminum is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

• The other excipients are:

Sodium hydroxide, sodium chloride, and water for injections.

Appearance and package contents

diTeBooster is a colorless or pale yellow liquid with white and gray particles.

Each dose is provided as a pre-filled syringe or vial.

Package sizes: 1 x 0.5 ml, 5 x 0.5 ml, 10 x 0.5 ml, and 20 x 0.5 ml.

Vial size: 1 x 0.5 ml, 5 x 0.5 ml, and 10 x 0.5 ml.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

AJ Vaccines A/S,

5, Artillerivej,

2300 Copenhagen S,

Denmark.

tel.: +45 7229 7000

fax: +45 7229 7999

e-mail: [email protected]

You can request further information about this medicine from the local representative of the marketing authorization holder:

MEDICARE PHARMA, S.L.

Pº de la Castellana, 177 3ºB

28046 Madrid, Spain

Tel. 91 3395489

This medicine is authorized in the Member States of the European Economic Area under the following names:

AT, DK, EL, ES, FI, IE, PT, NO, SE: diTeBooster

DE: Td-IMMUN

This leaflet was last revised in January 2024

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This information is intended only for healthcare professionals:

diTeBooster is used for the revaccination of children (≥ 5 years of age) and adults who have received primary immunization with at least 3 doses of diphtheria and tetanus vaccine.

diTeBooster is used to vaccinate children (≥ 5 years of age) and adults who have forgotten, not completed, or not received primary vaccination against diphtheria and tetanus.

diTeBooster can be used in the case of deep or potentially contaminated wounds, as prevention against tetanus and as a booster against diphtheria.

The use of diTeBooster should be carried out following local official recommendations.

Shake before use. After thorough resuspension, the vaccine should appear as a colorless or pale yellow suspension of white and gray particles.

The dose is 0.5 ml, administered intramuscularly.

Administration of booster doses of the diphtheria and tetanus vaccine should be carried out at intervals indicated by official recommendations (generally every 10 years). Too frequent booster vaccination will increase the risk of adverse reactions.

Individuals with unknown immune status or incomplete primary vaccination may be vaccinated with diTeBooster. More than one vaccine may be necessary to achieve protective immunity against diphtheria and tetanus. National recommendations should be followed.

In individuals with bleeding disorders, diTeBooster may be administered subcutaneously. Clinical studies have shown that fewer local reactions occur with intramuscular injection than with subcutaneous injection.

Necessary precautions should always be taken for the treatment of anaphylactic reactions.

The final product may contain trace amounts of formaldehyde used during the manufacturing process. Caution should be exercised in subjects with known hypersensitivity to formaldehyde.

Do not mix diTeBooster with other vaccines in the same syringe.

Concomitant administration of diTeBooster with other inactivated vaccines has not been studied. It is unlikely that concomitant administration will interfere with immune responses. If necessary, diTeBooster can be administered simultaneously with other vaccines, at a different injection site.

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.